Promazine Zentiva

Italy
Brand name Promazine Zentiva
Form drops, oral solution
Active substance / Dosage
Promazine
Prescription type Prescription only
ATC code
N05AA03
Registration number 047227
Manufacturer ZENTIVA ITALIA S.R.L.

Table of Contents

Package leaflet: Information for the user

Promazina Zentiva 40 mg/ml oral drops, solution

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
    1. What Promazina Zentiva is and what it is used for
    2. What you need to know before taking Promazina Zentiva
    3. How to take Promazina Zentiva
    4. Possible side effects
    5. How to store Promazina Zentiva
    6. Package contents and other information

1. What Promazina Zentiva is and what it is used for

Promazina Zentiva is a medicine containing the active substance promazine hydrochloride, which belongs to the class of phenothiazine antipsychotics.
Promazine is indicated for the treatment of psychomotor agitation or aggressive behaviour. This medicine is also indicated for the treatment of schizophrenia and other mental disorders.

2. What you should know before taking Promazina Zentiva

Do not take Promazina Zentiva:

  • if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to other medicines containing phenothiazine antipsychotics (e.g. chlorpromazine, thioridazine) or other phenothiazines (e.g. promethazine);
  • if you have reduced red blood cells and/or white blood cells and/or platelets in the blood, signs of bone marrow depression;
  • if you have a tumor of a gland called “adrenal gland” causing high blood pressure (pheochromocytoma);
  • if you have reduced senses, drowsiness or lack of coordination, blurred vision, confused speech or reduced awareness of your surroundings (central nervous system depression).

Promazina Zentiva must not be administered to patients in a state of coma.
Warnings and precautions
Talk to your doctor or pharmacist before taking Promazina Zentiva.
Inform your doctor before taking Promazina Zentiva:

  • if you have previously experienced a reduction in certain types of white blood cells called granulocytes (agranulocytosis) caused by other medicines;
  • if you are taking medicines for the treatment of certain cancers (antineoplastics), because this medicine may mask the toxic effects of some of these drugs;
  • if you have circulatory problems (cardiovascular and cerebrovascular diseases), because this medicine may cause temporary blood pressure problems (orthostatic hypotension);
  • if you have suffered from epilepsy or seizure disorders, as the seizure threshold may be lowered;
  • if you are at risk of increased body temperature, for example if you have engaged in intense physical activity, have been exposed to high temperatures, are taking anticholinergic medicines, or are at risk of dehydration;
  • if you are elderly, especially if you suffer from advanced Alzheimer’s dementia, as in this case you may be more prone to esophageal motility disorders and breathing problems (e.g. aspiration pneumonia);
  • if you have had liver problems or jaundice (yellowing of the skin and whites of the eyes). If you develop liver problems during treatment with this medicine, your doctor will need to perform certain tests to monitor liver function. If severe liver problems occur, your doctor will discontinue treatment with this medicine;
  • if you have had a stroke or are in a condition that may increase your risk of stroke, for example high blood pressure, diabetes, high cholesterol or if you smoke;
  • if you have had heart problems or if someone in your family has or has had a heart condition called QT interval prolongation. In this case, avoid taking other medicines called neuroleptics (medicines used to treat certain mental disorders);
  • if you or someone in your family has had blood clotting disorders;
  • if you have or have previously had a condition of the eye called closed-angle glaucoma (characterized by increased eye pressure, accompanied by pain and blurred vision);
  • if you suffer from a bowel condition called paralytic ileus;
  • if you suffer from Parkinson’s disease;
  • if you suffer from a chronic disease causing muscle weakness accompanied by fatigue called myasthenia gravis;
  • if you have an enlarged prostate (a condition called prostatic hypertrophy).

STOP TAKING Promazina Zentiva and inform your doctor immediately if during
treatment with this medicine you experience:

  • a group of symptoms including body temperature increase above 40°C, muscle rigidity or fatigue, altered mental status, heart or blood pressure problems, kidney problems, rhabdomyolysis (breakdown of skeletal muscle cells), as this could be a life-threatening condition called “Neuroleptic Malignant Syndrome”;
  • a condition called tardive dyskinesia characterized by abnormal and involuntary body movements;
  • significant changes in mood, including suicidal thoughts. Inform your doctor if during treatment with Promazina Zentiva you experience:
  • muscle tremors, constant need to move, or abnormal movements of the face and body. Your doctor will decide whether to discontinue treatment or manage these symptoms with appropriate therapy.

During treatment with this medicine, avoid direct exposure to sunlight. This is because
taking this medicine may make you more sensitive to strong sunlight.
Your doctor should perform regular checks of your central nervous system, liver, bone marrow, eyes, and
cardiovascular system during treatment with this medicine.
Children and adolescents
Do not use Promazina Zentiva in children and adolescents under 12 years of age.
Other medicines and Promazina Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Do not use this medicine if you are taking:

  • medicines that cause a reduction in red blood cells and/or white blood cells and/or platelets in the blood (bone marrow depression);
  • medicines that alter heart rhythm (QT interval prolongation), as this increases the risk of heart problems (cardiac arrhythmias);
  • medicines that may alter levels of minerals (electrolytes) in the blood;
  • antibiotics such as moxifloxacin, as this increases the risk of heart problems (cardiac arrhythmias);
  • levodopa, a medicine used to treat Parkinson’s disease, as promazine may reduce the effect of levodopa. Use this medicine with extreme caution and inform your doctor if you are taking:
  • other medicines acting on the central nervous system;
  • barbiturates, used to treat sleep disorders;
  • anxiolytics/hypnotics for the treatment of anxiety;
  • anesthetics, used during surgical procedures;
  • antihistamines, used to treat allergies;
  • analgesics, including opioid analgesics, used to treat pain. Indeed, the use of the above-mentioned medicines may increase the effects of promazine on the central nervous system; this could lead to respiratory depression, central nervous system depression, and low blood pressure (hypotension).

Also use this medicine with extreme caution and inform your doctor if you are taking any of the
following medicines:

  • anticonvulsant medicines, used to treat epilepsy and seizures: promazine may reduce the effect of anticonvulsants;
  • succinylcholine, used during surgical procedures;
  • metrizamide, used as a contrast agent for radiological examinations of the spinal cord: concomitant use of promazine and metrizamide may increase the risk of seizures. Your doctor will ask you to stop taking promazine at least 48 hours before undergoing a radiological examination of the spinal cord and will ask you to resume taking promazine 24 hours after the examination;
  • lithium, used to treat certain mental disorders. If your doctor prescribes promazine while you are on lithium therapy, you must be closely monitored for the appearance of such symptoms;
  • medicines used to treat cancer (antineoplastics): promazine may reduce nausea and vomiting symptoms, thereby masking the toxic effects of some of these medicines;
  • anticholinergics, medicines used to treat irritable bowel syndrome, asthma, or incontinence;
  • antacids, used to reduce stomach acidity, as they may reduce the absorption of promazine;
  • antihypertensives, used to treat high blood pressure.

Promazina Zentiva may cause:

  • darkening of the urine, may alter the results of certain laboratory tests (amylase test, urobilinogen, urinary porphyrins, porphobilinogens, and 5-hydroxyindoleacetic acid);
  • false positive results in pregnancy tests in women.

Promazina Zentiva with food, drinks and alcohol
Promazina Zentiva may enhance the depressant effects of alcohol when taken simultaneously. Avoid drinking alcoholic beverages during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine if you are pregnant or breastfeeding unless your doctor considers it absolutely necessary.
Newborns of mothers who have used promazine during the third trimester of pregnancy may experience the following
symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding problems. If your child shows any of these symptoms, you must inform your doctor immediately.
Driving and using machines
The use of Promazina Zentiva may affect your ability to drive or operate machinery. Avoid driving or operating machinery if you experience sedation, dizziness or drowsiness.
Promazina Zentiva contains sodium, sorbitol and propylene glycol

  • This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.
  • This medicine contains 4970 mg of sorbitol per maximum daily dose in adults (i.e. in 400 mg of Promazina Zentiva, equivalent to 200 drops), equivalent to 7.1 mg/kg per ml of solution. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
  • This medicine contains 1500 mg of propylene glycol per maximum daily dose in adults (i.e. in 400 mg of Promazina Zentiva, equivalent to 200 drops), equivalent to 21.43 mg/kg/day.

3. How to take Promazina Zentiva

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Promazina Zentiva is for oral use only.
If your symptoms are acute and require rapid intervention, injectable formulations of promazine may be necessary. Your doctor will provide you with the necessary information and prescribe the most suitable formulation for you.

Recommended dose:
Adults: 15 drops 4 times daily (120 mg daily). The maximum dose is 50 drops 4 times daily (400 mg daily). The initial dose is 10–15 drops daily (20–30 mg daily), given as a single evening dose, which your doctor may increase as needed.
Children over 12 years of age and adolescents: 5–15 drops daily (10–30 mg daily). The maximum dose is 15 drops 4 times daily (120 mg daily).
Elderly patients: 10–30 drops daily (20–60 mg daily). The maximum dose is 25 drops 4 times daily (200 mg daily).

When the daily dose exceeds 25 drops (50 mg), your doctor will advise dividing the dose into 2–4 administrations per day.

Use in patients with liver problems
If you have liver problems, your doctor will prescribe the most appropriate dose for you.

Method of administration:
Promazina Zentiva drops must be taken orally, diluted in water.
To dispense the drops, turn the bottle upside down and hold it vertically with the opening facing downward.

If you take more Promazina Zentiva than you should
In case of accidental ingestion or overdose of Promazina Zentiva, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.
After taking an excessive dose of Promazina Zentiva, you may experience the following symptoms:
difficulty breathing, drowsiness or impaired coordination, blurred vision, difficulty speaking, loss of contact with reality (central nervous system depression), confusion, indifference or lack of motivation (apathy), disturbances in cognition (cognitive disorders), low blood pressure, decreased body temperature, reduced blood flow in the heart vessels (myocardial ischemia), increased or irregular heartbeat (tachycardia, arrhythmia), abnormal body postures due to involuntary muscle contractions (dystonia), seizures.

If you forget to take Promazina Zentiva
Do not take a double dose to make up for the missed dose.

If you stop taking Promazina Zentiva
Continue taking Promazina Zentiva for as long as your doctor tells you to. Your doctor will gradually reduce your dose. If you stop taking the medicine abruptly, you may experience the following withdrawal symptoms:

  • nausea and vomiting;
  • dizziness;
  • difficulty staying still (restlessness);
  • tremors.

If you have any questions about the use of this medicine, consult your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Promazina Zentiva immediately and contact your doctor if you experience any of the following:

  • difficulty breathing;
  • body temperature above 40 °C, muscle rigidity, altered mental status, irregular heartbeat (tachycardia, arrhythmias) or blood pressure, excessive sweating, unusual changes in the amount or appearance of urine produced (acute renal failure), signs of Neuroleptic Malignant Syndrome;
  • sudden drop in blood pressure due to reduced blood volume (hypovolemic shock);
  • extrapyramidal symptoms (especially when used at high doses), including:
    • motor restlessness with inability to sit or stand still (akathisia), which usually occurs after the first dose;
    • abnormal movements of the face and body (dystonia), more common in children and young people, and may appear after a few doses;
    • tremor, muscle stiffness, and slowed movements (parkinsonism), more common in adults and elderly patients, developing gradually during treatment;
    • indifference or lack of purpose (apathy), confusion;
    • loss of muscle coordination (ataxia), cognitive disturbances, fainting (syncope).

Inform your doctor if, during treatment with Promazina Zentiva, you notice:

  • blood abnormalities such as: reduced number of certain types of white blood cells like granulocytes (agranulocytosis) or neutrophils (neutropenia), formation of blood clots within blood vessels (disseminated intravascular coagulation);
  • changes in blood tests such as: increased TSH, increased transaminases, increased alkaline phosphatase, increased creatine phosphokinase;
  • heart problems (T-wave inversion, QT interval prolongation);
  • breathing problems (respiratory failure);
  • severe liver problems (hepatitis);
  • sudden or gradual appearance of skin lesions, for example, color changes in spots or widespread (erythema);
  • muscle problems such as muscle damage (rhabdomyolysis) and muscle stiffness;
  • impaired kidney function (acute renal failure);
  • excessive increase in body temperature (hyperthermia) and fever;
  • nausea, vomiting, dizziness, tremors, and restlessness occurring when stopping the medicine abruptly (withdrawal symptoms);
  • overdose, intentional poisoning.

Other side effects
Some side effects observed with other medicines containing promazine or other phenothiazines may also occur during treatment with Promazina Zentiva. These include:

  • allergic-type reactions including: skin rash with possible sudden drop in blood pressure (anaphylactic reactions), difficulty breathing (bronchospasm, laryngospasm), swelling of the face or throat due to fluid accumulation (laryngeal edema);
  • reduced number of red blood cells (aplastic anemia, hemolytic anemia) and/or platelets (thrombocytopenia) and/or white blood cells (leukopenia), increased eosinophil count (eosinophilia);
  • increased blood sugar levels (hyperglycemia) and presence of sugar in urine (glycosuria);
  • inability to sleep (insomnia), difficulty staying still (restlessness), anxiety, depression, mood changes (euphoric mood);
  • extrapyramidal symptoms such as motor restlessness (akathisia), abnormal movements of the face and body (dystonia), Parkinson-like symptoms such as tremors and stiffness (parkinsonism), slow movements or difficulty initiating movement, and involuntary movements mainly affecting facial muscles and tongue (tardive dyskinesia);
  • drowsiness, seizures, dizziness, sedation, profuse sweating;
  • vision disorders such as blurred vision, deposits in the lens, corneal lesions, pupil dilation (mydriasis), retinal disorders (retinopathy);
  • changes in heart rhythm (ventricular arrhythmias such as torsades de pointes), increased heart rate (ventricular tachycardia, ventricular fibrillation), cardiac arrest, sudden death;
  • sudden drop in blood pressure upon rapidly changing from a sitting or lying position to standing (orthostatic hypotension); fainting (syncope);
  • esophageal disorders and respiratory tract inflammation (aspiration pneumonia);
  • constipation (stipsis), dry mouth (xerostomia);
  • yellowing of the skin or whites of the eyes (jaundice);
  • skin irritation (exfoliative dermatitis, photosensitivity, eczema, erythema, urticaria, skin pigmentation);
  • a disease characterized by red skin spots and bleeding (purpura);
  • skin rashes, joint disorders, connective tissue problems, and blood disorders caused by an autoimmune disease (systemic lupus erythematosus);
  • reduced urine output (urinary retention);
  • breast enlargement (gynecomastia), sudden milk production (galactorrhea), absence of menstrual periods (amenorrhea) in women, menstrual cycle disturbances (menstrual disorders), inability to achieve or maintain an erection in men (erectile dysfunction);
  • increase or decrease in body temperature, weight gain, swelling of limbs due to fluid accumulation (peripheral edema);
  • swelling, pain, and redness in the legs caused by blood clots. Clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing: contact your doctor immediately if you experience these symptoms;
  • worsening of mental disorders (psychotic symptoms).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Promazina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and outer carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the bottle tightly closed.
Store in the original packaging to protect from light.
The product should be used within 2 months of first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Promazina Zentiva contains

  • The active substance is promazine hydrochloride. 1 ml of solution contains: 45.1 mg promazine hydrochloride equivalent to 40 mg promazine base. One drop corresponds to 2 mg of promazine.
  • The other components are non-crystallizable liquid sorbitol, anhydrous sodium citrate, anhydrous citric acid, propylene glycol, disodium edetate, purified water.

Description of the appearance of Promazina Zentiva and contents of the pack
Amber glass bottle of 30 ml oral solution, equipped with a polyethylene dropper cap with child-resistant closure.
Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7, 20121 Milan - Italy.
Responsible manufacturer for batch release
Chanelle Medical, Dublin Road, Loughrea, H62 FH90 County Galway, Ireland